Persistent facial erythema is the
most common sign of rosacea3
RHOFADE® cream is the first and only α1A adrenoceptor agonist approved for the topical treatment of persistent facial erythema associated with rosacea in adults1
RHOFADE® cream significantly improved erythema with lasting results2
|Hour on Day 29||RHOFADE® Cream(n = 222; P < 0.05 vs vehicle)||Vehicle(n = 218)|
|Hour on Day 29||RHOFADE® Cream(n = 224; P < 0.05 vs vehicle)||Vehicle(n = 221)|
CEA = Clinician Erythema Assessment. SSA = Subject Self-Assessment for rosacea facial redness.
Results of 2 identical 29-day, randomized, double-blind, parallel-group, vehicle-controlled studies to evaluate the safety and effectiveness of once-daily RHOFADE® cream in 885 subjects with moderate to severe persistent facial erythema associated with rosacea. The primary end point was the proportion of subjects with at least a 2-grade improvement in erythema from baseline (pre-dose on day 1) on both the CEA and SSA scales measured at hours 3, 6, 9, and 12 on day 29.1
To achieve composite success, physicians and subjects had to independently rate the change in erythema as a 2-grade or greater improvement on similar 5-point scales.1
Composite success was required to meet the primary end point1
RHOFADE® cream significantly improved erythema with lasting results—a step closer to a more normal, healthy skin color1,2
In pivotal trials, few subjects discontinued due to adverse events
(2.2% with RHOFADE® cream vs 0.2% with vehicle)2
|Adverse Reaction||RHOFADE® Cream
|Application-site dermatitis||9 (2%)||0|
|Worsening inflammatory lesions of rosacea||7 (1%)||1 (< 1%)|
|Application-site pruritus||5 (1%)||4 (1%)|
|Application-site erythema||5 (1%)||2 (< 1%)|
|Application-site pain||4 (1%)||1 (< 1%)|
|Adverse Reaction||RHOFADE® Cream
|Worsening inflammatory lesions of rosacea||14 (3%)|
|Application-site dermatitis||13 (3%)|
|Application-site pruritus||9 (2%)|
|Application-site pain||9 (2%)|
|Application-site erythema||7 (2%)|
Apply 1 pea-sized amount once a day—every day—in a thin layer to cover the entire face (forehead, nose, each cheek, and chin), avoiding the eyes and lips1
Wash hands immediately after application1
Not for oral, ophthalmic, or intravaginal use1
Continue to avoid common triggers
Most commercially insured patients pay about $1/day or less for once-a-day—every day—RHOFADE® cream
*Estimate based on the average daily use of RHOFADE® cream in clinical trials. In phase 3 clinical trials, mean daily usage was 0.43 grams per day.2 Therefore, a 30-gram tube used daily would last approximately 70 days.
†Limitations apply. Uninsured and government-insured patients are not eligible for these offers.
RHOFADE® (oxymetazoline HCl) cream 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Alpha-adrenergic agonists may impact blood pressure. RHOFADE® cream should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
RHOFADE® cream should be used with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
RHOFADE® cream may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
The most common adverse reactions for RHOFADE® cream were: application-site dermatitis 2%, worsening inflammatory lesions of rosacea 1%, application-site pruritus 1%, application-site erythema 1%, and application-site pain 1%.
Please see full Prescribing Information for RHOFADE® cream.